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Risk management

As a partner to our customers, we share responsibility for the mutual work. This concern extends far beyond development and production. Even after market launch, we assume the risk management for each individual product. If modifications are required, our customers can rely on the fact that we will provide feedback and the necessary adaptation by our company.

Therefore our security officers observe permanently the market for potential risks. Professional publications and institutions are important sources of information for them, as well as the exchange with experts and customers. A network of clinical partners gives our company first-hand clinical reviews. At the same time they offer professional support in the development of new implant systems.

The staff of Regulatory Affairs monitors changes in legal regulations and directives. As a result, draft standards at EU level can be inspected long before regulations become effective, furthermore planning reliability increases. For this purpose, our regulatory staff keeps in close contact with MEDCERT as the notified body for the Testing and Certification of Quality Management Systems and Medical Devices and ZLG, the German Central Federal Office for the Protection of Health for Pharmaceutical Prodcuts and Medical Devices